Femoroacetabular Impingement SyndromeNCT04946513
Hip Arthroscopy Improves Muscle Volumes in Patients With Femoroacetabular Impingement Syndrome
An observational study of Femoroacetabular Impingement Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
To explore the changes of the muscles around the hip joint after hip arthroscopy for patients with femoral acetabular impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femoroacetabular Impingement Syndrome
- What is being tested?
- Muscle volumes were measured on pre- and postoperative MRI scans.
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with femoroacetabular impingement syndrome and underwent hip arthroscopy.
Inclusion Criteria: (1) Age 18-50 years old; (2) Diagnosed femoroacetabular impingement syndrome; (3) Conservative treatment ineffective; (4) complete preoperative and postoperative MRI images; -
Exclusion Criteria: (1) bilateral; (2) revision; (3) osteoarthritis; (4) acetabular dysplasia; (5) history of hip and knee joint disease or surgery; (6) femoral head necrosis; (7) sacroiliac joint disease.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Hip Arthroscopy on Postoperative Muscle Volumes in Patients With Femoroacetabular Impingement Syndrome
To explore the changes of the muscles around the hip joint after hip arthroscopy for patients with femoral acetabular impingement syndrome.
Read the detailed description
Retrospectively investigate the influence of hip arthroscopy on the muscle volume around the hip joint, and to provide important information for clinicians to make diagnosis and treatment plan of hip joint disease.
- Conditions
- Femoroacetabular Impingement Syndrome
- Being tested
- Muscle volumes were measured on pre- and postoperative MRI scans.
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle volumes were measured on pre- and postoperative MRI scans.Other
Muscle volumes were measured on pre- and postoperative MRI scans.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with femoroacetabular impingement syndrome and underwent hip arthroscopy。 Receives: Other: Muscle volumes were measured on pre- and postoperative MRI scans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle volumes
Difference between pre- and postoperative muscle volumes
Measured: 1 year after hip arthroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Nov 2019
- Primary completion1 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian-quan Wang, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946513
- Sponsor's protocol ID
- M2019451
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Hip Arthroscopy on Postoperative Muscle Volumes in Patients With Femoroacetabular Impingement Syndrome
- ClinicalTrials.gov ID
- NCT04946513
- Acronym / sponsor ID
- M2019451
- Conditions
- Femoroacetabular Impingement Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the changes of the muscles around the hip joint after hip arthroscopy for patients with femoral acetabular impingement syndrome.
Detailed description
Retrospectively investigate the influence of hip arthroscopy on the muscle volume around the hip joint, and to provide important information for clinicians to make diagnosis and treatment plan of hip joint disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Muscle volumes were measured on pre- and postoperative MRI scans.Patients with femoroacetabular impingement syndrome and underwent hip arthroscopy。 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with femoroacetabular impingement syndrome and underwent hip arthroscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle volumes were measured on pre- and postoperative MRI scans.Muscle volumes were measured on pre- and postoperative MRI scans. | Other | Group 1 |
Primary outcome
Muscle volumes
Time frame: 1 year after hip arthroscopy
Difference between pre- and postoperative muscle volumes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-quan Wang, M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoroacetabular Impingement Syndrome, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle volumes (time frame: 1 year after hip arthroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.